The centerpiece of GINA lies in its broad definitions of genetic information and genetic test. Genetic information includes information about an individual or a family member's genetic tests, information about manifestation of a disease in a family member, information about receipt of genetic services and information about participation in clinical research that involves genetic services. Family members include an individual's dependents and first, second, third or fourth degree relatives. Group health plans and health insurers are prohibited from collecting genetic information for underwriting purposes, such as determining eligibility for benefits or setting premiums or employee contribution levels. They are also prohibited from requesting or requiring that an individual or a family member undergo a genetic test.
A genetic test
refers to any analysis that detects geno-types, genetic mutations or chromosomal changes. It does not include an analysis of proteins or metabolites that is directly related to a manifested disease. Consequently, it does not change the rules on how group health plans and insurers acquire or use information about an enrollee's history of genetic or any other type of illness. Nor does it prevent the insurance company from increasing an employer's premium based on the manifestation of a disease of an employee already enrolled in the plan. As an example, GINA protects a woman who has had a genetic test that reveals that she has a BRAC1 or a BRAC2 mutation, as long as she does not have breast cancer. Once she has breast cancer, she is no longer protected by the act, whether or not her disease was genetically caused. The Act also does not cover other types of insurance, such as long-term care insurance and disability insurance. The long-term care industry has, so far successfully, argued that permitting individuals to get predictive genetic testing, like APOE testing, and then letting them use that information to decide whether to purchase long-term care insurance without disclosing the results, could put the insurers out of business.2
The Act places restrictions on the collection and uses of genetic information in employment by generally prohibiting employers from requesting or requiring genetic information of an employee or a family member. Exceptions include the inadvertent acquisition of medical history information, voluntary employer-sponsored wellness programs and health services, and genetic monitoring programs required by state or federal law to track the biological effects of toxins in the workplace. Like virtually all federal laws, this one will require extensive federal regulations, yet to be written, to spell out how it will work in practice. Employment rules are set to go into effect in October, 2009 and health insurance rules will not be fully in effect until January, 2010.